Indications & Usage Section
Hypercalm - Mental Focus Formulated for symptoms associated with hyperactivity such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.
Hypercalm - Mental Focus
FDA Label NDC 55714-1514
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Hypercalm - Mental Focus (NDC 55714-1514). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration Section
ORAL USE ONLY - SHAKE WELL. Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
Otc - Active Ingredient Section
Adrenalinum 15x, Tarentula cubensis 15x, Aconitum nap. 10x, Arg. nit. 10x, Arsenicum alb. 10x, Baptisia 10x, Chamomilla 10x, Coffea cruda 10x, Cypripedium 10x, Digitalis 10x, Gelsemium 10x, Humulus 10x, Hyoscyamus 10x, Ignatia 10x, Impatiens glandulifera flos 10x, Iodium 10x, Lachesis 10x, Lycopodium 10x, Nat. mur. 10x, Nux vom. 10x, Scutellaria lateriflora 10x, Staphysag. 10x, Stramonium 10x, Theridion 10x, Veratrum viride 10x, Chamomilla 3x, Echinacea 3x, Hypericum 3x, Passiflora 3x.
Otc - Purpose Section
Formulated for symptoms associated with hyperactivity such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.
Inactive Ingredient Section
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.
Questions Section
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA30012
Questions? 1.800.448.7256
Warnings Section
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding Section
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Package Label
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